Cleared Traditional

ANGIOJET ULTRA POWER PULSE KIT

K130381 · Medrad, Inc. · Cardiovascular

Jul 2013

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K130381 is an FDA 510(k) clearance for the ANGIOJET ULTRA POWER PULSE KIT, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Medrad, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 29, 2013, 165 days after receiving the submission on February 14, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K130381 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2013
Decision Date	July 29, 2013
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QEW — Peripheral Mechanical Thrombectomy With Aspiration
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.